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NCT06853704: TPA
The Clinical Effects of Using Collagen Matrix in Papilla Augmentation: a Prospective Clinical Trial. Augmenting Fibro-Gide in Interdental Area Using Tunneling Technique to Treat Black Triangles (Papilla Loss)
Phase 2, PHASE3 trial testing papillary unit advancement in Dental Papilla Loss, Black Triangles in 8 participants. Completed in 8 September 2024.
20 July 2024
Quick facts
| Lead sponsor | King Abdullah University Hospital |
|---|---|
| Phase | Phase 2, PHASE3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 8 |
| Start date | 15 June 2023 |
| Primary completion | 20 July 2024 |
| Estimated completion | 8 September 2024 |
| Sites | 1 location across Jordan |
Drugs / interventions tested
- papillary unit advancement
Conditions studied
- Dental Papilla Loss, Black Triangles — all drugs for Dental Papilla Loss, Black Triangles →
- Black Traingles — all drugs for Black Traingles →
- Interdental Papillae Reconstruction — all drugs for Interdental Papillae Reconstruction →
- Interdental Papilla Augmentation — all drugs for Interdental Papilla Augmentation →
Sponsor
King Abdullah University Hospital
Who can join
18 and older, any sex, with Dental Papilla Loss, Black Triangles or Black Traingles. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Black triangles, also known as open gingival embrasures, are usually the result of the lack of papilla fill interdentally. With the improvement of dental procedures and materials, more attention has been directed to improving this unesthetic occurrence. Improvement of papilla loss (black triangle) can be mainly categorized into non-surgical and surgical techniques with most surgical modalities focused on a minimally invasive approach due to the restricted working area and blood supply to the papilla. Collagen matrix offers strong mechanical properties while promoting tissue healing and hence is used in many periodontal plastic surgeries (gum surgeries). However, the outcome of collagen matrix in treating papilla loss has not been studied yet. This study aimed to see at the clinical effects of collagen matrix in papilla augmentation using a minimally invasive surgical approach. Patients with papillae loss were selected and Collagen matrix (Geistlich Fibro-Gide) used to stabilize the affected area with a minimally invasive surgical procedure. Papilla height gain, texture and color will be assessed pre-operatively, three and six months postoperatively. in addition, probing depth, clinical attachment level and keratinized tissue width will also be assessed.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06853704 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by King Abdullah University Hospital
- Last refreshed: 3 March 2025
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